The status of diabetes control and antidiabetic drug therapy in Japan—A cross-sectional survey of 17,000 patients with diabetes mellitus (JDDM 1)

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Abstract

The number of diabetic patients has been increasing in Japan and consequently diabetic complications are the most important target to be prevented through improving glycemic control. In order to describe the glycemic control status and treatment of diabetic patients by specialists in Japan over three years, from 2000 to 2002, we examined HbA1c, other laboratory data and the modality of drug therapy in the study population, 8170 in 2000, 11,831 in 2001, and 16,934 in 2002. Patients were registered at clinics and hospitals that were members of the Japan Diabetes Clinical Data Management Study Group (JDDM). HbA1c levels, other laboratory data, and details of drug therapy were collected and analyzed using SPSS and MS Access. The mean HbA1c levels were essentially unchanged during the study periods, ranging from 7.9% to 7.8%, and from 7.1% to 7.0%, in type 1 and type 2 diabetic patients, respectively. In type 2 diabetes, the frequency of oral hypoglycemic agents (OHA) use increased from 44.9% to 51.4%, while the use of diet-only therapy decreased from 29.9% to 25.4% over the study period. Although the systolic blood pressure was slightly above target, the mean blood pressure and the mean lipid profile were mostly within the treatment goals set by the Japan Diabetes Society. This first report from a large scale study of the daily management of diabetes in Japan revealed that the average HbA1c level was superior to most of the results reported from other countries. Nonetheless, 66% of the patients still had HbA1c levels and half of the patients had other laboratory parameters including blood pressure and lipid profile that were greater than those recommended by the Japan Diabetes Society. The nature of diabetes drug therapy in Japan has gradually changed as new drugs have appeared in the market.

Introduction

The incidence and prevalence of type 2 diabetes mellitus are rapidly increasing worldwide in both developing and developed nations [1], [2]. The WHO projected the number of adults with diabetes to increase from 135 million in 1995 to 300 million in 2025, with the prevalence predicted to increase from 4.0% in 1995 to 5.4% in 2025 [1]. Such a dramatic rise in the prevalence of diabetes will have a great impact on the socioeconomic status of nations around the world.

The number of diabetic patients is also increasing in Japan. A recent national survey showed that between 1997 and 2002 the number of probable diabetic patients has increased from 6.9 million to 7.4 million and the number of probable impaired glucose tolerance (IGT) patients has increased from 6.8 million to 8.8 million [3]. Thus, 16.2 million people out of a total population of 120 million, or 13.5% of the population, are diabetic or have IGT. The prevalence of diabetes and IGT in adults of more than 40 years of age is around 23.8% [3]. These patients are at a significantly higher risk of diabetic complications if adequate medical care and patient education are not provided. The cost of treating diabetic complications, especially diabetic nephropathy that requires hemodialysis, continues to increase. Therefore, it is vital that diabetes mellitus is adequately managed to prevent such complications.

The effectiveness of medical care provided to diabetic patients can be estimated from an outcome study that analyzes the level of glucose control. Such outcome studies are necessary to determine the present status of diabetes medical care and the level of diabetic complications that may emerge in the future. A large-scale survey of the effectiveness of medical care in diabetes has not been performed in Japan. Therefore, we addressed this deficiency by surveying 38 clinics and hospitals. Laboratory data relating to diabetic medical treatment and complications, such as HbA1c and other clinical data, were collected and analyzed. The data show that Japan's medical performance in diabetes care is comparable or slightly superior to that of other countries.

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Patients and methods

In 1998, we developed software (CoDiC) to store patient clinical data on personal computers [4], standardized the data format including the definition of type 1 and type 2 diabetes and complications, and recruited clinics and hospitals to join our Japan Diabetes Clinical Data Management Study Group (JDDM). The number of institutes recruited was 21 by the end of 2000, 25 by the end of 2001 and 38 by the end of 2002. At the end of January 2004, the total number of institutes stood at 61. The

Demographics

The clinical characteristics of the patients are summarized in Table 1. The majority of patients (95%) were diagnosed as having type 2 diabetes. The mean age of all the patients in 2002 was 61.9 ± 11.9 years, with the majority (59.2%) aged between 50 years and 70 years. The percentages of male and female patients were 60.5% and 39.5%, respectively. The mean body mass index (BMI, kg/m2) in 2002 was 24.0 kg/m2 with 46.9% exceeding the Japanese criteria for obesity (BMI  25 kg/m2) [7].

HbA1c values, patient type and treatment modality

As shown in Table

Discussion

Diabetic outcome studies were important for understanding the current management of diabetes and thereby improving the diabetic treatment. For example, in Asia, the glycemic control of a significant number of diabetic patients is poor [9], [10]. Consequently, these patients will develop more severe diabetic complications if further intervention is not taken [9], [10]. Collecting clinical data is not simple because of potential biases in selecting patients. The Japan Diabetes Clinical Data

Acknowledgments

This study was supported by a grant from Japan Diabetes Foundation. The software system ‘CoDiC’ was constructed by a support of Novo Nordisk Pharma Ltd. (Tokyo, Japan).

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